Revaxis

Quick links to important sections

Revaxis

Method of action: Vaccine

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Revaxis

Property Description
Active Ingredients Diphtheria Toxoid, Tetanus Toxoid, Inactivated Poliomyelitis Virus (Types 1, 2, 3)
Form Suspension for injection
Pharmacological Class Vaccines, Combined Viral and Bacterial (ATC Code: J07CA01)
Common Use Booster for active immunisation against Diphtheria, Tetanus, and Polio
Origin Biological (Toxoids and Inactivated Virus)
Rx Status Prescription Only Medicine (POM)

Revaxis is classified as a combined vaccine within the high-level pharmacological class of Vaccines, Combined Viral and Bacterial, intended for active immunisation against three serious infectious diseases: diphtheria, tetanus, and poliomyelitis (polio). This medicine is explicitly designated as a booster vaccine for individuals from six years of age who have previously completed a primary vaccination series, and it is not intended for primary immunisation. The vaccine is designed to induce high protective antibody levels against all three components, supporting the maintenance of long-term seroprotection.

The formulation contains three core active ingredients: the Purified Diphtheria Toxoid, the Purified Tetanus Toxoid, and the Inactivated Poliomyelitis Virus (comprising serotypes Type 1, Type 2, and Type 3). This composition is classified as Td/IPV, where the lowercase "d" signifies the reduced antigen(s) content of the diphtheria component, differentiating it from formulations used earlier in life. The components are of biological origin/type—the bacterial toxins are modified into harmless toxoids, and the poliovirus is completely inactivated, meaning they cannot cause the diseases they prevent.

As a pharmaceutical preparation, Revaxis is presented as an adsorbed vaccine, supplied as a suspension for injection. It contains Aluminium Hydroxide, which serves as an adsorbent to stabilize the immune response. The general purpose is preventative: it sustains effective protection memory throughout adolescence and adulthood, providing continued defense against diphtheria, tetanus, and poliomyelitis.

What side effects are possible with Revaxis?

The safety profile for Revaxis is primarily structured around adverse reactions categorized by frequency and the affected body system, as documented in regulatory labeling.

Frequency-Classified Adverse Reactions

The most frequent effects are generally transient and short-lived. The regulatory framework classifies reactions as:

  • Very Common (Affecting >1 in 10 people): Local injection site reactions, including pain, swelling (oedema), redness (erythema), and induration (hardening), typically appearing within 48 hours and lasting 1 to 2 days. Systemic effects commonly include headache and general malaise.
  • Common (Affecting le 1 in 10 people): Systemic effects such as fever (pyrexia), nausea, vomiting, and dizziness (vertigo).
  • Uncommon/Rare: Less frequent effects include swollen glands (lymphadenopathy), muscle pains (myalgia), and joint pains (arthralgia).

Serious Adverse Reactions and Safety Constraints

The label documents rare but serious events, often reported from post-marketing surveillance with an uncalculated frequency (Not Known). These include anaphylactic reactions (severe systemic allergic response), Guillain-Barré syndrome (GBS), brachial neuritis (neuropathy of the arm/shoulder), and convulsions.

Official safety constraints note that the vaccine must not be administered intravascularly. Postponement is required for individuals with acute severe febrile illness or a progressive or unstable neurological disorder. Individuals with coagulation disorders or thrombocytopenia must be given caution due to the risk of bruising or bleeding at the injection site.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents state that no specific cases of overdose have been reported with Revaxis, meaning a unique pharmacological overdose syndrome is not formally documented in the labeling. Consequently, any potential effects from an excessive dose are generally expected to be exaggerated known adverse reactions.

Overdose Scope Official Regulatory Information
Documented Manifestations No unique overdose symptoms are listed; the focus is on life-threatening systemic allergic reactions (anaphylaxis/shock) that require immediate action.
Physiological Systems Affected Immune, Respiratory, and Cardiovascular systems are relevant, with signs including difficulty in breathing, fainting (collapse), and low blood pressure.
Emergency-Response Statement Appropriate medical treatment and supervision must be readily available for immediate use in the event of an anaphylactic reaction. Management is symptomatic and supportive.
When Urgent Help is Required If signs of a serious allergic reaction, such as swelling of the face or throat, occur after leaving the place of injection, the patient must consult a doctor IMMEDIATELY.

The regulatory profile is defined by the absence of a documented toxic overdose, shifting focus to mandatory emergency preparedness for rare, severe systemic adverse events. The official guidance requires patients to seek immediate medical attention if symptoms such as collapse or difficulty breathing occur, confirming the regulator's emphasis on rapid response to acute allergic risks.

Therapeutic Uses of Revaxis

What Revaxis Treats: Main Uses and Benefits

Revaxis is a combined booster vaccine applied across domains where additional symptomatic support is needed against three serious infectious diseases: Diphtheria, Tetanus, and Poliomyelitis (Polio). This vaccine is generally indicated for children from six years of age, adolescents, and adults as a booster following primary vaccination. The vaccine is relevant for easing symptoms related to increased neurological or muscular activity, such as severe muscle spasms, rigidity, and potential paralysis linked to Tetanus and Polio.

It is commonly used to help with maintaining long-term seroprotection throughout adolescence and adulthood, and is considered relevant in clinical settings for managing tetanus-prone injuries (e.g., deep cuts). The central therapeutic benefit is the ability to help maintain functional stability and general well-being.

“The use is relevant for supporting the body's defense against the severe manifestations of Diphtheria, Tetanus, and Poliomyelitis.”


Quick Fact: Context: Supporting Functional Stability

The vaccine is applied in addressing the overall symptom burden associated with systemic imbalance and symptoms linked to organ-specific functional stress.

Eligibility and Restrictions for Use

Who Can and Cannot Use Revaxis?

Revaxis is an official booster vaccine indicated for individuals who have already completed a primary vaccination course against diphtheria, tetanus, and poliomyelitis. It is authorized for use in children from six years of age, adolescents, and adults, but is strictly not intended for primary immunisation.

Contraindicated Populations

Use is contraindicated in individuals with a known hypersensitivity to the active substances, vaccine components, or trace residuals like neomycin or polymyxin B. It must also be withheld from those who experienced neurological complications following a prior diphtheria or tetanus vaccine.

Restricted or Conditional Use

Vaccination must be postponed in the presence of an acute severe febrile illness. The vaccine is not recommended if the individual received a booster containing diphtheria or tetanus toxoids within the previous five years. Use requires caution in subjects with a bleeding disorder or immunosuppression, where the immune response may be reduced. Revaxis should not be administered during pregnancy unless there is an urgent need to boost immunity, but it can be given during breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Revaxis defines the interaction profile primarily through pharmacodynamic effects and administration restrictions, rather than metabolic interactions.


Documented Pharmacodynamic and Procedural Interactions

Interaction Type Interacting Substance/Class Official Regulatory Statement
Pharmacodynamic Immunosuppressive agents (e.g., steroids, chemotherapy) Co-administration may lead to reduced immunogenicity and a limited antibody response.
Procedural (Timing/Site) Other vaccines or immunoglobulins Revaxis may be administered at the same time, provided the injections are made at a separate anatomical site (e.g., a different limb).
Procedural (Physical Mixing) Other medicinal products The product must not be mixed with any other medicinal products in the same syringe or vial.

Interaction Context

The official product information notes that vaccination is still recommended for immunosuppressed subjects, even though the expected protective antibody response may be limited. The interaction profile for this combined vaccine is characterized by the absence of documented pharmacokinetic interactions, such as those mediated by CYP enzymes or drug transporters, with co-administered medicinal products. The small quantity of ethanol anhydrous present as an excipient is officially documented as having no noticeable effects on the recipient.

Mechanism of Action

Revaxis is a booster vaccine composed of purified toxoids from Corynebacterium diphtheriae and Clostridium tetani, and inactivated polioviruses (types 1, 2, and 3), adsorbed onto an aluminum salt adjuvant.

Upon intramuscular injection, the antigen components are delivered to the local tissue microenvironment. The adjuvant, aluminum hydroxide, acts by forming a depot at the injection site, facilitating sustained antigen presence. Antigen-presenting cells (APCs), primarily dendritic cells, phagocytose the antigen-adjuvant complex. The aluminum salt component triggers the NLRP3 inflammasome pathway within the APCs, leading to the processing and secretion of pro-inflammatory cytokines, such as interleukin-1 beta (IL-1beta).

Antigen presentation by the APCs to naïve and memory T-cells and B-cells occurs in the draining lymph nodes. This cellular interaction and the costimulatory signaling cascade induce the proliferation and differentiation of CD4^+ T helper cells and the activation of antigen-specific B-lymphocytes. B-cell activation leads to clonal expansion and differentiation into plasma cells, which are the primary effector cells for humoral immunity. These plasma cells initiate the de novo synthesis and secretion of antigen-specific antibodies ( IgG, IgM) targeting the diphtheria toxoid, tetanus toxoid, and poliovirus antigens. Furthermore, the process generates long-lived B and T memory cells. This system-level physiological modulation results in an anamnestic immune response, characterized by a rapid and amplified increase in specific circulating antibody titers upon subsequent antigen exposure.

Dosage and Administration Information

How to Use Revaxis: Administration Guidelines

This section outlines the administration guidelines for the use of Revaxis, which is a vaccine administered as a booster dose for individuals previously vaccinated against diphtheria, tetanus, and poliomyelitis.

Administration Scope

Feature Official Instruction
Route of Administration Intramuscular (IM) injection only, preferably into the deltoid region of the upper arm. The intravascular route must not be used. A deep subcutaneous injection is permitted for persons with bleeding disorders.
Dosing Rule The required dose is 0.5 ml per administration.
Target Population Children from the age of six years, adolescents, and adults.
Preparation The pre-filled syringe must be shaken well to create a uniform suspension immediately before use. The syringe should be visually inspected for foreign particles or discoloration.

Procedural Structure

The use of Revaxis involves a defined procedural sequence:

  1. Inspection: The vaccine should be visually inspected for any particles or change in appearance.
  2. Shaking: The syringe must be shaken thoroughly just prior to injection.
  3. Dose Administration: The entire 0.5 ml dose is to be administered as an intramuscular injection into the deltoid muscle.

Co-Administration

Revaxis may be given at the same time as other vaccines or immunoglobulins, provided that a separate injection site is used for each product. For example, a different limb should be used.

Recent Clinical Evidence

Research evidence / Overview of studies for Revaxis

The information presented here is a summary of how the research community has studied Revaxis. It describes the types of studies conducted, the measurements taken, and the known limits of the current evidence base, without offering clinical guidance or stating efficacy.


Evidence for use as a Booster against Diphtheria, Tetanus, and Polio

Research has explored Revaxis using study designs that include randomized, comparative clinical studies. These studies were conducted to explore the measured immune response when the vaccine was administered as a booster to individuals who had already received a primary vaccination course. Researchers monitored specific immune system outcomes, such as the measurement of pre-defined antibody level thresholds against Diphtheria Toxoid, Tetanus Toxoid, and all three types of Poliovirus.

Studies reported measurements indicating that the majority of participants reached the pre-defined antibody level threshold one month after administration. Findings describe patterns observed in the studies related to antibody levels post-booster. It is important to note that this vaccine was not studied for the purpose of primary immunisation. Compared to formulations containing higher amounts of diphtheria components, the reported average antibody levels in some studies may differ, although the measured seroprotective threshold appears to be met in the studied populations.


Research on Use in Acute Tetanus-Prone Injuries

The research exploring the use of Tetanus-containing vaccines, including Revaxis, in the context of an acute tetanus-prone injury, draws on broader clinical policy and observational data. Research has explored the immune response to Td-containing vaccines when administered as part of acute injury management. These studies monitored the rapid rise in antibody levels against Tetanus Toxoid. Comparative evidence, however, is lacking from dedicated studies that specifically compare Revaxis against all other Td/IPV products in the immediate, acute injury scenario.


Long-Term Studies and Durability of Protection

Research has monitored antibody levels over defined time intervals. Intermediate-term studies have explored the persistence of measured antibody levels for a few years following the booster dose. However, follow-up durations were limited in some trials. As a result, there is limited information for long-term outcomes that fully characterizes antibody persistence and the continued monitoring of immune markers beyond the intermediate follow-up windows.

Frequently Asked Questions (FAQ)

Common questions about Revaxis (FAQ)

Q: Why is Revaxis often referred to as the '3-in-1 teenage booster'?

The term '3-in-1 teenage booster' is a common nickname. This is because the vaccine protects against three diseases—diphtheria, tetanus, and polio. It is frequently administered as a routine booster to young people around the age of 13 or 14 years in some national vaccination schedules.


Q: How long can a person expect the protection from Revaxis to last?

Official research information notes that data on the very long-term persistence of the vaccine's protection is limited. For continued defense against tetanus and diphtheria, authoritative health guidance typically describes the need for a booster vaccination approximately every 10 years after the previous dose.


Q: What is the full recommended primary and booster schedule for the tetanus, diphtheria, and polio vaccines?

Official documents classify Revaxis as a booster dose intended for individuals who have already completed a full primary vaccination course. The specific primary schedule (number of doses and intervals) is determined by national guidelines and childhood vaccines received earlier in life. Subsequent tetanus-containing boosters are generally given every 10 years to help maintain seroprotection.


Q: What are the known signs of a severe allergic reaction (anaphylaxis) to Revaxis?

The official label notes that serious allergic reactions, known as anaphylaxis, are a rare event after vaccination. Signs of a severe reaction described in health resources include swelling of the eyes, lips, or throat, difficulty breathing or swallowing, and feeling faint or lightheaded.


Q: Is there a concern about receiving Revaxis while having a minor illness, such as a cold?

According to official product information, the presence of a minor infection, such as a common cold without a fever, is generally not considered a reason to delay the vaccination. However, if an individual has an acute severe illness accompanied by a high temperature, the administration of Revaxis is generally recommended for postponement.


Q: How is the safety and effectiveness of Revaxis monitored by health authorities after approval?

The safety of Revaxis is monitored on an ongoing basis through post-marketing surveillance conducted by national regulatory agencies. This process relies on reports from healthcare professionals and the public regarding any suspected side effects. Effectiveness is also continuously reviewed through clinical follow-up and public health programs.


Q: Why is a booster dose of tetanus, diphtheria, and polio needed later in life?

Booster doses are needed because the protective level of antibodies against tetanus, diphtheria, and polio naturally fades over time after the primary vaccination series. Booster vaccinations are administered to rapidly reactivate the body's immune memory. This action is intended to help restore seroprotection.


Q: Is it possible to experience extensive swelling of the vaccinated limb after the shot?

Yes, the vaccine label documents that large reactions at the injection site are possible, although the exact frequency is unknown. This can include extensive swelling of the entire vaccinated limb that may extend beyond one or both nearby joints. These reactions typically resolve within 3 to 5 days.


Q: What should be done if someone feels dizzy or lightheaded immediately after the Revaxis injection?

Dizziness (vertigo) is listed as a possible side effect in the official product information. If this symptom occurs, the official guidance states the recipient should avoid driving or operating machinery. Healthcare facilities also have procedures in place to manage and prevent injury from fainting, which can occur as a psychological response to the injection process.


Q: Does Revaxis contain any ingredients that may be relevant to a person with Phenylketonuria (PKU)?

Yes, the official product information notes that Revaxis contains a small amount of phenylalanine as an excipient. Phenylalanine may be harmful to individuals diagnosed with phenylketonuria (PKU).


Q: Is the Revaxis vaccine routinely required for all types of international travel?

The vaccine is not routinely required for all international travel. Official health sources state that Revaxis may be recommended if an individual's last dose was more than 10 years ago, or if they are traveling to areas with limited access to medical help or a higher risk of these diseases.


Q: What types of occupations or activities might necessitate an extra dose of the Revaxis vaccine?

Official health guidance indicates the vaccine may be required for certain occupations, such as those with an elevated risk of exposure to tetanus. It is also used as part of the official management protocol for certain tetanus-prone wounds, as defined by national guidelines.


Q: What does the patient information leaflet say about driving or operating machinery after the injection?

The official patient information states that dizziness (vertigo) has been reported as a side effect following vaccination. If this symptom occurs, the official patient information indicates the recipient should avoid driving or operating machinery until the dizziness has fully passed.


Q: What kind of documentation or records should be kept after receiving Revaxis?

Administrative guidance for healthcare professionals indicates that details such as the vaccine's batch number must be recorded. Individuals may also receive a patient-held record card or vaccine passport to document the administration, which is useful for tracking future booster needs.


Q: What is the difference between a tetanus toxoid and the tetanus disease?

The tetanus toxoid is the inactive component within the vaccine; it is a modified version of the bacterial toxin that cannot cause illness. Tetanus disease (or lockjaw) is the serious infection caused by the actual bacteria, which releases toxins that lead to severe muscle spasms and convulsions.

How should Revaxis be stored and disposed of?

Revaxis must be stored in a refrigerator to maintain the integrity of the vaccine components. Official product labeling mandates a precise temperature range of 2 C to 8 C.

Storage Conditions and Handling

  • Freezing is Prohibited: The vaccine must not be frozen. If the product has been frozen, it must be discarded immediately, as freezing compromises its stability.
  • Protection from Light: The pre-filled syringe must be kept in the original package to protect the contents from light.
  • Child Safety: Like all medicines, the product must be kept out of the sight and reach of children.

Disposal Instructions

Any unused Revaxis or associated waste material must be disposed of in accordance with local requirements. Equipment such as the syringe and needle are considered sharps and must be handled and discarded following local guidelines for pharmaceutical and medical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Revaxis found in:

A-Z Index: